The present invention relates to a device for introducing two-component fibrin adhesive into a puncture channel in the vicinity of an arterial or venal puncture location, according to the preamble of patent claim 1.
Many human and vetinary medical operations demand the puncturing of vessels. In particular with percutaneous transluminar coronary angioplasty (PTCA), heart operations and heart catheterisations the punctured vessels must be closed again with the utmost care. In most cases this is effected by way of direct compression of up to one hour and a pressure compress which must be applied for up to 24 hours and demand 1 to 2 days hospital attendance. As a result there is the desire to find a solution which leads to a quick and secure closure of the puncture location.
On the occasion of a meeting American Heart Association of Nov. 17, 1992 in New Orleans there was presented a method under the description of Vasoseal. With this method in each case two collagen plug of bovine collagen were injected into a puncture channel up to the location of puncture. At the mentioned meeting it was ascertained that apart from the rather seldom rejection reactions of the collagen foreign to the body there arise various further disadvantages or risks. It was ascertained that this system in many cases is ineffective and there exists a certain embolism danger. With about 46% of all cases there formed haemtomas of the magnitude of 2-6 cm. Up to the complete resorption of the bovine collagen there passes weeks to months.
This method leads furthermore to an enlarged scar formation which makes an ultrasound control more difficult. Finally the hospitalisation did not become superfluous but was at least shortened. One of the essential problems however lies in the handling, i.e. the introduction of the collagen plug into the puncture channel. Since after one another two collagen plug must be pressed into the puncture channel, the penetration for example depth for the user is difficult to ascertain. If the collagen plug are injected too deep then the collagen plug may be pushed through the puncture location into the vessel which would lead to a closure or the vessel itself is pressed closed. A new method in order to close such puncture locations quickly, reliably and without the disadvantageous collagen plug has been disclosed by the inventor in WO 94/28798.
From FR-A-2378528 there is known a double-lumen catheter for carrying out a haemodialysis. With this the blood to be dialysised is removed through the exterior lumen and through the interior lumen there is supplied the dialysised blood. The outer lumen at the same time surrounds the inner lumen at a distance and both lumens during the dialysis are introduced into the vessel of the patient.
According to EP-A-0xe2x80x2482xe2x80x2350 there is suggested an apparatus which normally is pushed over the guidewire and with which a plug is inserted into the puncture channel. Although the dilator has a smaller diameter than the cannula into which the guidewire is guided, the resistance which the cardiologist is aware on introduction is so small so that there is an extremely real danger of the outer cannula of the apparatus piercing into the vessel to be sealed. Thus then the plug is placed into the vessel instead of the puncture channel. This danger has been recognised and therefore in the same application it has been suggested, by way of a needle clamp, to measure the penetration depth of the needle when the guidewire is introduced.
It has been shown that with the use of the body""s own blood coagulation agents extracted from blood protein in the form of two-component fibrin adhesive whose components at the moment of introduction are mixed and this mixture during or directly after an intravascular operation are introduced into the puncture channel as close as possible to the vessel, there arises an optimal vessel closure. Histological examinations have confirmed these facts.
The solution of sealing the puncture channel with a two-component fibrin adhesive has a high functional safety, as various clinical trials have shown. In spite of the use of blood thinning agents a perfect sealing could not be achieved.
Whilst with the first clinical trials pactically no erroneous handlings were ascertained it has been shown that the high functional safety leads to the fact that with a further series of trials one worked very quickly and the guidelines with respect to precautionary measures were not observed. Accordingly there resulted partly insufficient sealings which required subsequent treatment. Unfortunately the sealing was carried out either too deep, by which means a part of the fibrin adhesive came into the vessel, or the sealing was carried out too far away from the vessel wall, by which means the undelivered fibrin adhesive externally penetrated ushed out on the cannula wall along the puncture channel.
As a consequence it is the object of the present invention to provide a device by way of which fibrin adhesive may be introduced into a puncture channel as exact as possible in the vicinity of an arterial or venal puncture location.
This object is achieved by a device which comprises a sealing cannula which is axially passed through by a working cannula from above to below, wherein the working cannula which serves the intravascular introduction of an instrumentation into a vessel is surrounded by the sealing cannula at a distance so that the fibrin adhesive is led from a connection piece at least from one radially aligned exit opening in the sealing cannula between this cannula and the working cannula, with the features of patent claim 1.
Further advantageous embodiment forms of the device are deduced from the dependent claims, and their significance and advantages are explained in the subsequent description.